Palvella Therapeutics Inc Stock Price, News & Analysis

Palvella Therapeutics (NASDAQ: PVLA) announced a new topical product candidate, QTORIN™ pitavastatin, for disseminated superficial actinic porokeratosis (DSAP), a rare premalignant genetic skin disease with no FDA‑approved therapies and an estimated >50,000 diagnosed U.S. patients.

The company plans an FDA meeting in the first half of 2026 to discuss a proposed Phase 2 design and anticipates initiating the Phase 2 trial in the second half of 2026. Palvella cited genetic evidence and published case studies supporting topical statins and highlighted pitavastatin's potency as rationale for development. A webcast conference call was held on November 5, 2025 to discuss the candidate.

Palvella Therapeutics (Nasdaq: PVLA) will report third quarter 2025 financial results before market open on Tuesday, November 11, 2025. Management will host a conference call for investors at 8:30 a.m. ET the same day to discuss results and provide a corporate update.

A live webcast with slides will be available via the company's Events & Presentations page and a phone registration link will supply dial-in details. A replay of the webcast will be posted approximately 2 hours after the call and will be archived for 90 days at www.palvellatx.com.

Palvella Therapeutics (NASDAQ:PVLA) received Year Two funding from the FDA Office of Orphan Products Development for its Phase 3 SELVA trial of QTORIN™ 3.9% rapamycin for microcystic lymphatic malformations.

The grant provides up to $2.6 million in non-dilutive funding over four years. SELVA is a 24-week, single-arm, baseline-controlled trial that enrolled 51 subjects (target 40) and remains on track for top-line results in Q1 2026. Palvella plans an NDA submission in the second half of 2026 assuming positive results. QTORIN has Breakthrough Therapy, Orphan Drug, and Fast Track designations and could qualify for 7 years of U.S. orphan exclusivity if approved.

Palvella Therapeutics (NASDAQ: PVLA) announced the expansion of its QTORIN™ rapamycin development program to include treatment of Clinically Significant Angiokeratomas, a rare lymphatic disease affecting over 50,000 diagnosed patients in the U.S. with no FDA-approved therapies.

The company plans to initiate a Phase 2 trial in the second half of 2026, involving 10-20 patients, following FDA discussions in H1 2026. This marks QTORIN™ rapamycin's third target indication, alongside ongoing trials for microcystic lymphatic malformations (Phase 3 SELVA study) and cutaneous venous malformations (Phase 2 TOIVA study).

Top-line results are expected from TOIVA in December 2025 and SELVA in Q1 2026.

Palvella Therapeutics (NASDAQ:PVLA) announced the publication of significant research in Lymphatic Research and Biology regarding venous malformations (VMs) and rapamycin treatment. The systematic review, analyzing 26 studies with 98 patients, reinforces the scientific basis for Palvella's QTORIN™ 3.9% rapamycin anhydrous gel.

The research highlights the PI3K/AKT/mTOR pathway as a key driver of VM disease progression and documents the effectiveness of rapamycin in treating VMs. The company's Phase 2 TOIVA trial, which enrolled 16 patients, is evaluating QTORIN™ rapamycin for cutaneous VMs, with top-line data expected in mid-December 2025. The treatment received FDA Fast Track Designation in April 2024, targeting an estimated 75,000+ diagnosed patients in the U.S. who currently lack FDA-approved therapies.

Palvella Therapeutics (NASDAQ:PVLA) has completed enrollment in its Phase 2 TOIVA trial for QTORIN™ rapamycin, a potential first-in-class treatment for cutaneous venous malformations (VMs). The trial successfully enrolled 16 subjects at leading vascular anomaly centers, meeting its target of approximately 15 participants.

QTORIN™ rapamycin is a novel 3.9% rapamycin anhydrous gel designed to treat VMs, which affect an estimated 75,000+ U.S. patients. The drug aims to inhibit mTOR signaling while minimizing systemic exposure. The single-arm, open-label study will evaluate safety, tolerability, and efficacy through multiple measures, with top-line results expected in mid-December 2025.

Palvella Therapeutics (NASDAQ:PVLA) has appointed David W. Osborne, Ph.D. as Chief Innovation Officer. Dr. Osborne, co-founder and former Chief Technical Officer of Arcutis Biotherapeutics, brings over 25 years of experience in topical drug development and is an inventor on 52 U.S. patents and over 200 foreign patents.

In his new role, Dr. Osborne will lead Palvella's early-stage R&D pipeline and maximize the potential of the company's proprietary QTORIN™ platform, which develops targeted topical therapies for rare genetic skin diseases. The company plans to announce its second QTORIN™ product candidate by year-end 2025.

Dr. Osborne's notable achievements include contributing to the development of three dozen topical therapies, including ZORYVE® cream and foam, and holding senior roles at several pharmaceutical companies where he helped develop multiple FDA-approved therapies.

Palvella Therapeutics (NASDAQ:PVLA), a clinical-stage biopharmaceutical company developing therapies for rare genetic skin diseases, has announced upcoming presentations at two major healthcare investor conferences. CEO Wes Kaupinen will present at the Cantor Global Healthcare Conference on September 4, 2025, at 2:45 PM ET and the H.C. Wainwright Global Investment Conference on September 8, 2025, at 10:30 AM ET.

The presentations will be accessible via live webcast on Palvella's website, with replays available for approximately 90 days afterward.

Palvella Therapeutics (NASDAQ:PVLA) reported Q2 2025 financial results and provided updates on its clinical programs. The company's Phase 3 SELVA trial for QTORIN™ rapamycin in microcystic lymphatic malformations exceeded enrollment targets by 25%, with top-line results expected in Q1 2026. The Phase 2 TOIVA trial for cutaneous venous malformations remains on track for Q4 2025 results.

Financial highlights include $70.4 million in cash as of June 30, 2025, expected to fund operations into H2 2027. Q2 2025 saw a net loss of $9.5 million ($0.86 per share). The company plans to announce both a third clinical indication for QTORIN™ rapamycin and a second QTORIN™ platform candidate by year-end 2025.